This study is a sub-study of CISMACs main BCG trial and aims to evaluate and compare the cost-effectiveness of giving the BCG vaccine either a birth or at 14 weeks of age.
Economic evaluation of the timing of BCG-vaccination in HIV-exposed babies
The Bacillus Calmette-Guérin (BCG) vaccine protects children against primary tuberculosis, but it might also have positive health effects beyond that, so called non-specific effects (NSEs). It is unclear if such NSEs are also seen in children born to HIV-1 positive women, i.e. HIV-1 exposed infants, and if these effects depend on the timing when the vaccine is given. An ongoing randomized controlled trial in Uganda is currently assessing effects of enforcing BCG on the day of birth versus giving it at 14 weeks of age on the risk of severe illness (a proxy for serious clinical infection) in HIV-1 exposed infants.
Besides these possible clinical benefits, it is important to estimate the cost-effectiveness of these two different vaccination schedules. The analysis in this add-on study will include household costs already being collected in CISMAC’s Trial “Early Versus Late BCG Vaccination in HIV-1 exposed infants”, and will expand the information by collecting data on health provider costs. Provider costs encompass both the intervention costs related to ensuring timely BCG vaccination, as well as costs of managing the illnesses that the vaccine may prevent through the NSEs. We will use statistical approaches to estimate cost implications for the children from birth up until 5 years of age, and decision modelling to compare the cost-effectiveness of the two vaccination strategies.
The study findings can be used to inform stakeholders involved in the development of appropriate child vaccination schedules.
Victoria Nankabirwa, Makerere University, Uganda, and University of Bergen, Norway
Bjarne Robberstad, University of Bergen, Norway
Steve Kabanda, Makerere University, Uganda